20 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01
FDA 510(k)
FDA Class 2
·Immunology
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE
FDA 510(k)
FDA Class 2
·Orthopedic
MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120
FDA 510(k)
FDA Class 2
·Cardiovascular
G2 FILTER SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·August 21, 2007
RECOVERY G2 FILTER SYSTEM, FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·July 23, 2007
G2 FILTER SYSTEM - FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·August 19, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 17, 2013
INTERLINK SYSTEM BASIC SOLNSET INJ SITE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·April 19, 2011
OLYMPUS
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code KNS·June 17, 2008
RECOVERY G2 FILTER SYSTEM - FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·February 5, 2010
RECOVERY G2 FILTER SYSTEM - FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·September 15, 2009
G2 FILTER SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·September 21, 2007
BD ONCLARITY HPV ASSAY REAGENT PACK
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MAQ·August 2, 2023
BD FACS 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 30, 2020
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025
RECOVERY G2 FILTER SYSTEM, FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·July 27, 2007
Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the lead for a trial procedure or to extend the lead when a permanent IPG is implanted. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual
FDA Enforcement
Class II
·Terminated·Boston Scientific Neuromodulation Corporation·June 3, 2020
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015